| Primary Device ID | D080SSEPXXX36XLXC20 |
| NIH Device Record Key | 0e3490fc-fde9-460c-a2ae-84eca2a96f13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EFUCERA PX |
| Version Model Number | 8*1SET,36,L,C2 |
| Company DUNS | 693430001 |
| Company Name | YAMAHACHI DENTAL MFG.,CO. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |